FDAFDA · Food and drugs·Recall number Z-2339-2017
VIDAS Testosterone, Ref 30418
Published July 19, 2017 · Recall initiated: May 15, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- bioMerieux, Inc.
- Distributor
- AR, CA, CO, GA, IL, IA, MI, MN, MT, NY, OK, TN, TX, WY, Columbia, Costa Rica, El Salvador, France, Hong Kong, Jordan, Nicaragua, Russian Fed., Sri Lanka, Sweden, Ukraine
- Lot
- Lots 1004878310 & 1005001080
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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